Descripción de la oferta
Experteer Overview
In this role you lead CSV and Test Management for Straumann’s Global Business Applications, driving validated ERP and enterprise solutions like SAP and Salesforce. You will shape CSV standards, oversee lifecycle documentation, and support global compliance through training and audits. You will collaborate with IT, QA, and business stakeholders during a digital transformation and major initiatives such as S/4HANA. This is a hands-on leadership position with cross-functional impact and regulatory accountability.
Compensaciones / Beneficios
• Manage validation documentation across SDLC with stakeholders (validation strategy, test plans, user requirements, functional/configuration specs, SOPs, test records)
• Provide CSV guidance to implementation or update project teams
• Continuously improve CSV standards to align with IT and QA and regulatory changes
• Define, drive and implement Test Management for Business Applications and initiatives like S/4HANA
• Coordinate with QA, Compliance, and Test teams to align deliverables with CSV guidelines
• Coordinate local CSV and QA representatives to meet global CSV compliance requirements
• Provide training and coaching on CSV standards and testing approaches
• Collaborate with SAP and other Business Application stakeholders to ensure compliance and project quality
• Participate in internal and external audits as needed
Responsabilidades
• 10+ years in CSV, QM, Test and Project Management with at least 2 years in a leadership role
• Strong expertise in GxP, 21 CFR Part 11, GAMP 5 and Annex11
• Experience establishing CSV/documentation best practices in regulated environments
• Strong project and test management skills with ability to deliver compliance-focused outputs
• Familiarity with multiple software development methodologies and adapting them for CSV
• Excellent communication and stakeholder management skills
• Resilience and adaptability to challenges
• Fluent English; additional language (German) is an asset
Requisitos principales
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